North Star Dairy – FDA Warning Letter, Sep 17, 2012

On September 10, 14, and 17, 2012, the FDA investigated North Star Dairy, LLC. and found violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on April 9, 2012, was found to have unsafe levels of cefazolin in its kidney tissue, rendering the food adulterated under section 402(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records and segregate treated animals, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, which adulterates food under section 402(a)(4).

Furthermore, North Star Dairy adulterated new animal drugs (ceftiofur hydrochloride, ceftiofur, and ceftiofur sodium) by using them extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and rendering the drugs unsafe and adulterated under sections 512(a) and 501(a)(5). Specifically, a ceftiofur drug was administered to a dairy cow without adhering to the stated withdrawal period.

Additionally, the company provided a false Producer's Wholesomeness Certificate on September 15, 2008, for the cow found with violative cefazolin residue